MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT ALUM.TRANSPORT WC 12 IN WLS BLUE 9153643817; WHEELCHAIR, MECHANICAL

Model Number ALB19HBFR

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer alleges the left footrest assembly came apart on a (b)(4) transport chair.

• Brand Name: ALUM.TRANSPORT WC 12 IN WLS BLUE 9153643817
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• MDR Report Key: 4510285
• MDR Text Key: 5443103
• Report Number: 1531186-2015-00943
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/11/2015,02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ALB19HBFR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2015
• Distributor Facility Aware Date: 02/05/2015
• Date Report to Manufacturer: 02/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other